Derivation of Tumor Specific Hybridomas

NCT ID: NCT01702792

Last Updated: 2018-04-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-05-06

Brief Summary

This is a non-randomized, open-label study in patients with newly diagnosed glioblastoma to determine the ability to generate human hybridomas from lymph nodes draining an autologous tumor vaccine injection and demonstrate that the hybridomas secrete glioblastoma-specific antibodies.

Detailed Description

The intradermal vaccine will be injected 20cm in the anterior thigh. Vaccination will be done twice and separated by one week. The first vaccination will be performed approximately 2 weeks after surgery.

Approximately one week after the second vaccination one or two vaccine-draining lymph node(s) will be removed. The lymph node(s) will be identified using SN technology. One or two lymph node(s) will be removed.

Lymph nodes will be processed for recovery of B cells and formation of hybridomas.

Conditions

Glioblastoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tumor Vaccine

1 x 107 TCE tumor lysate in 0.5 ml Lactated Ringers Solution (approximately 1 mg of tumor lysate protein) and equivalent volume of adjuvant will be injected 2 weeks and 3 weeks (2 vaccinations) after surgery in the intradermal skin of the upper thigh. There will be 2 vaccine administrations and patients will be followed for 2 months after inguinal node removal for any possible vaccine/study-related toxicity.

Group Type: EXPERIMENTAL

Tumor Vaccine

Intervention Type: BIOLOGICAL

Tumor cells obtained at the time of surgery are irradiated with 10,000 Gy and freeze fractured. Lysate at 1x107 tumor cell equivalent (TCE) will be used for vaccination with adjuvant, Montanide ISA 51 VG.

Interventions

Tumor Vaccine

Tumor cells obtained at the time of surgery are irradiated with 10,000 Gy and freeze fractured. Lysate at 1x107 tumor cell equivalent (TCE) will be used for vaccination with adjuvant, Montanide ISA 51 VG.

Intervention Type: BIOLOGICAL

Other Intervention Names

Autologous Tumor Lysate and Montanide Emulsion

Eligibility Criteria

Inclusion Criteria

• Patients with confirmed new diagnosis of glioblastoma and who have a yield of at least 8x10(7) tumor cells obtained at the time of surgery
• Age > 18 years
• KPS Score of greater than or equal to 70
• Adequate bone marrow as evidenced by:

Absolute lymphocyte count > 1,000/uL Platelet count > 50,000/uL

• Adequate renal function as evidenced by serum creatinine < 2.0
• Patients must be able to read, understand and provide informed consent to participate in the trial.
• Patients of childbearing potential must agree to use an effective form of contraception during the study and for 90 days following vaccination (an effective form of contraception is an oral contraceptive or a double barrier method)

Exclusion Criteria

A patient may not be enrolled in the trial if any of the following criteria are met:

• Patients receiving dexamethasone > 8 mg/day during the week before vaccination.
• Patients who are pregnant or lactating
• Patients with active second malignancy.
• Any other medical conditions, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Vermont

OTHER

Sponsor Role: collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Camilo Fadul, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Other Identifiers

W12209

Identifier Type: -

Identifier Source: org_study_id